Syndesmosis fixation and reconstruction system and method of using the same

Abstract

A fixation/reconstruction system for treating syndesmotic ankle fractures includes a screw guide assembly configured to align the cannulated screw for insertion into, and securing within, the patients bone; and, a tension band alignment assembly configured to insert at least one tension band through a transverse opening in the patient s leg, and to secure the tension band.

What is claimed is: 
     
       1. A fixation/reconstruction system comprising:
 a drill guide assembly comprising
 a screw driver securing end having a channel that defines a plurality of interior engaging surfaces for removably receiving a screw driver, 
 a tightening mechanism to secure the screw driver in the channel, 
 a drill guide bushing assembly including a threaded portion that engages a securing portion having a thumbwheel portion, wherein the threaded portion, the securing portion, and the thumbwheel portion each defines an internal opening, wherein the internal openings are aligned, 
 a slotted arcuate section that defines an arcuate opening for positioning of the drill guide bushing assembly, and 
 a cannulated drill bit guide configured to be received by the aligned internal openings of the drill guide bushing assembly; 
 
 a cannulated screw having a slot on a head end, at least one transverse opening, and an axially extending opening from the head end to a tip end of the cannulated screw; 
 a wedge having two parallel channels therethrough and being configured to engage the transverse opening; 
 a tension band; and 
 one or more fasteners. 
 
     
     
       2. The fixation/reconstruction system of  claim 1 , wherein:
 the drill guide assembly has the screw driver securing end and a drill guide end, the drill guide end defining a threaded opening configured to receive the tightening mechanism; 
 the tightening mechanism is threaded and has a distal end, wherein the tightening mechanism is configured to be able to be advanced toward the channel whereby, when the screw driver is within the channel, the distal end contacts the screw driver; 
 the drill guide end of the drill guide assembly has the slotted arcuate section; and 
 the drill guide bushing assembly is configured to be slidably positioned along the arcuate opening and to be secured in place with the thumbwheel portion. 
 
     
     
       3. A method for treating syndesmotic ankle fractures using the fixation/reconstruction system of  claim 2 , the fixation/reconstruction system including a screw driver, the method comprising:
 removably placing a screw-guide wire “S” into an intramedullary space of a distal fibula of an ankle, the guide wire “S” serving as a guide for the cannulated screw; 
 inserting the cannulated screw into the intramedullary space of the distal fibula; 
 securing the cannulated screw to prevent rotation within the fibula by removably engaging the slot of the cannulated screw with a tip of the screw driver by engaging a shaft of the screw driver within the channel defined by the plurality of interior engaging surfaces of the drill guide assembly, and securing the shaft by advancing a distal end of the tightening mechanism in a direction toward the shaft; 
 aligning the drill guide end of the drill guide assembly to a position adjacent the at least one transverse opening in the cannulated screw by positioning the drill guide bushing assembly along the arcuate opening in the slotted arcuate section; 
 passing a drill guide wire “B” through the cannulated drill bit guide, through the fibula, through the at least one transverse opening in the cannulated screw within the fibula; and through a tibia; the drill guide wire “B” serving as a guide for a cannulated drill to create a passage for the tension band; 
 forming the passage through the fibula and the tibia with the cannulated drill; 
 guiding a first end of the tension band through the fibula, through the at least one transverse opening in the cannulated screw, and through the tibia, and retrieving the first end of the tension band on a medial side of the tibia; 
 placing a first fastener of the one or more fasteners along a central portion of the tension band; 
 guiding the first end of the tension band back through the tibia, the at least one transverse opening of the cannulated screw, the fibula, and out of a patient's leg; and, 
 placing a second fastener of the one or more fasteners on the tension band, and securing the first end and a second end of the tension band, thereby allowing tightening and treatment of a syndesmosis. 
 
     
     
       4. The fixation/reconstruction system of  claim 1 , further including one or more of: a screw-guide wire “S”; a drill guide wire “B”; and the screw driver. 
     
     
       5. The fixation/reconstruction system of  claim 4 , including the screw driver, wherein:
 the screw driver has a shaft and a tip; 
 the tip has an axially extending threaded tightening mechanism; 
 the tip has opposing ears that are configured to engage the slot on the head end, providing a means to transmit torque to drive the cannulated screw and to align the cannulated screw to the drill guide assembly; and 
 the shaft defines a plurality of external engaging surfaces that have upper and lower shoulders that are configured to engage the drill guide assembly, positioning the shaft axially and rotationally with respect to the drill guide assembly. 
 
     
     
       6. The fixation/reconstruction system of  claim 1 , wherein the cannulated screw, the drill guide assembly, the tension band, and the one or more fasteners are packaged as a sterilized kit. 
     
     
       7. The fixation/reconstruction system of  claim 1 , wherein the cannulated screw, the drill guide assembly, the tension band, the one or more fasteners, a screw-guide wire “S”, a drill guide wire “B”, and the screw driver are packaged as a sterilized kit. 
     
     
       8. The fixation/reconstruction system of  claim 1 , wherein the cannulated screw is tapered and threaded on both the head end and the tip end, and has a non-threaded region between the head end and the tip end; and,
 wherein threads of the head end are of greater diameter and smaller pitch than threads of the tip end. 
 
     
     
       9. The fixation/reconstruction system of  claim 1 , wherein the cannulated screw is a headless full thread cannulated screw and is tapered from the head end to the tip end. 
     
     
       10. The fixation/reconstruction system of  claim 1 , wherein the cannulated screw is a headed compression cannulated screw having a diameter at the head end that is larger than the diameter of the tip end, and is threaded in both the head and tip ends; and, wherein the threads in the head end are of greater diameter and smaller pitch than the threads in the tip end. 
     
     
       11. The fixation/reconstruction system of  claim 1 , wherein the cannulated screw is a headed non-compression cannulated screw having the same threading in distal and proximal portions. 
     
     
       12. The fixation/reconstruction screw of  claim 1 , wherein the cannulated screw comprises a headless full thread cannulated screw wherein the headless full thread cannulated screw is tapered from the head end to the tip end. 
     
     
       13. The fixation/reconstruction screw of  claim 1 , wherein the cannulated screw comprises a headed non-compression cannulated screw having the same threading in distal and proximal portions. 
     
     
       14. A method for treating syndesmotic ankle fractures using the fixation/reconstruction system of  claim 1 , the method comprising:
 removably inserting a screw-guide wire “S” into an intramedullary space of a distal fibula of an ankle, the guide wire “S” serving as a guide for the cannulated screw; 
 inserting the cannulated screw into the intramedullary space of the distal fibula; 
 inserting a drill guide wire “B” through the at least one transverse opening in the cannulated screw; 
 drilling through the distal fibula and a tibia to create a passage for the tension band; 
 guiding a first end of the tension band through the passage in the fibula, the at least one transverse opening in the cannulated screw, and the passage in the tibia, and retrieving the first end of the tension band on a medial side of the tibia; 
 placing a first of the one or more fasteners along a central portion of the tension band; 
 guiding the first end of the tension band back through the tibia, the opening of the cannulated screw, and the fibula; 
 placing a second fastener of the one or more fasteners on a second end of the tension band; and, 
 securing the first and second ends of the tension band, thereby allowing tightening and treatment of a syndesmosis. 
 
     
     
       15. The fixation/reconstruction system of  claim 1 , wherein the wedge is configured to secure the tension band in the transverse opening. 
     
     
       16. The fixation/reconstruction system of  claim 1 , wherein the wedge includes a recessed area configured to contain knotting of the tension band. 
     
     
       17. A fixation/reconstruction system comprising:
 a drill guide assembly comprising
 a screw driver securing end having a channel that defines a plurality of interior engaging surfaces, 
 a tightening mechanism configured to secure a screw driver in the channel, 
 a drill guide bushing assembly including a threaded portion that engages a securing portion having a thumbwheel portion, wherein the threaded portion, the securing portion, and the thumbwheel portion each defines an internal opening, wherein the internal openings are aligned, 
 a slotted arcuate section that defines an arcuate opening for positioning of the drill guide bushing assembly, and 
 a cannulated drill bit guide configured to be received by the aligned internal openings of the drill guide bushing assembly; 
 
 a cannulated screw having at least one transverse opening; 
 a tension band; 
 a wedge having two parallel channels therethrough and being configured to secure the tension band in the transverse opening; and 
 one or more fasteners.